Cleared Traditional

K173309 - Faxitron VisionCT

K173309 is an FDA 510(k) clearance for Faxitron VisionCT, manufactured by Faxitron Bioptics, LLC. The device is a Class 2 Radiology device with product code MWP cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K173309 · Faxitron Bioptics, LLC · Radiology device
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May 2018
Decision
203d
Days
Class 2
Risk

K173309 is an FDA 510(k) clearance for the Faxitron VisionCT. Classified as Cabinet, X-ray System (product code MWP), Class II - Special Controls.

Submitted by Faxitron Bioptics, LLC (Tucson, US). The FDA issued a Cleared decision on May 9, 2018 after a review of 203 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Faxitron Bioptics, LLC devices

FDA 510(k) Submission Details - K173309

510(k) Number K173309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2017
Decision Date May 09, 2018
Days to Decision 203 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 107d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWP Device Classification - Class 2, Special Controls

Product Code MWP Cabinet, X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MWP Cabinet, X-ray System

All 22
Devices cleared under the same product code (MWP) and FDA review panel - the closest regulatory comparables to K173309.
Kubtec Mozart (Xpert42)
K183624 · Kub Technologies, Inc. · Jun 2019
PathVisionXL
K183142 · Faxitron Bioptics, LLC · Mar 2019
Trident HD Specimen Radiography System
K182727 · Hologic, Inc. · Jan 2019
Faxitron Bioptics Speciemen Radiography System
K170786 · Faxitron Bioptics, LLC · Jul 2017
BioVision Plus
K153583 · Faxitron Bioptics, LLC · Apr 2016
FAXITRON SPECIEN RADIOGRAPHY SYSTEM
K122428 · Faxitron Bioptics, LLC · Sep 2012